In vitro evaluation of a new viscoelastometry-based point-of-care analyzer.

INTRODUCTION: The VCM is a point-of-care analyzer using a new viscoelastometry technique for rapid assessment of hemostasis on fresh whole blood. Its characteristics would make it suitable for use in austere environments. The purpose of this study was to evaluate the VCM in terms of repeatability, reproducibility and interanalyzer correlation, reference values in our population, correlation with standard coagulation assays and platelet count, correlation with the TEG5000 analyzer and resistance to stress conditions mimicking an austere environment. METHODS: Repeatability, reproducibility, and interanalyzer correlation were performed on quality control samples (n = 10). Reference values were determined from blood donor samples (n = 60). Correlations with standard biological assays were assessed from ICU patients (n = 30) and blood donors (n = 60) samples. Correlation with the TEG5000 was assessed from blood donor samples. Evaluation of vibration resistance was performed on blood donor (n = 5) and quality control (n = 5) samples. RESULTS: The CVs for repeatability and reproducibility ranged from 0% to 11%. Interanalyzer correlation found correlation coefficients (r2) ranging from 0.927 to 0.997. Our reference values were consistent with those provided by the manufacturer. No robust correlation was found with conventional coagulation tests. The correlation with the TEG5000 was excellent with r2 ranging from 0.75 to 0.92. Resistance to stress conditions was excellent. CONCLUSION: The VCM analyzer is a reliable, easy-to-use instrument that correlates well with the TEG5000. Despite some logistical constraints, the results suggest that it can be used in austere environments. Further studies are required before its implementation.

Clinical utility of point-of-care glucose testing in the assessment of gestational diabetes: Prospective cohort study.

OBJECTIVE: To assess the clinical utility of point-of-care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT). DESIGN: Prospective cohort study. SETTING: Antenatal clinics at King's College Hospital. POPULATION: Women screened for GDM between March and June 2020. METHODS: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse-It 5.40.2. MAIN OUTCOME MEASURES: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method. RESULTS: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%-99%) and 97% (93%-98%) at fasting and 97% (91%-99%) and 79% (71%-84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%. CONCLUSIONS: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h.

Point-of-care ultrasound in pediatric anesthesiology: considerations for training and credentialing.

PURPOSE OF REVIEW: To discuss considerations surrounding the use of point-of-care ultrasound (POCUS) in pediatric anesthesiology. RECENT FINDINGS: POCUS is an indispensable tool in various medical specialties, including pediatric anesthesiology. Credentialing for POCUS should be considered to ensure that practitioners are able to acquire images, interpret them correctly, and use ultrasound to guide procedures safely and effectively. In the absence of formal guidelines for anesthesiology, current practice and oversight varies by institution. In this review, we will explore the significance of POCUS in pediatric anesthesiology, discuss credentialing, and compare the specific requirements and challenges currently associated with using POCUS in pediatric anesthesia. SUMMARY: Point-of-care ultrasound is being utilized by the pediatric anesthesiologist and has the potential to improve patient assessment, procedure guidance, and decision-making. Guidelines increase standardization and quality assurance procedures help maintain high-quality data. Credentialing standards for POCUS in pediatric anesthesiology are essential to ensure that practitioners have the necessary skills and knowledge to use this technology effectively and safely. Currently, there are no national pediatric POCUS guidelines to base credentialing processes on for pediatric anesthesia practices. Further work directed at establishing pediatric-specific curriculum goals and competency standards are needed to train current and future pediatric anesthesia providers and increase overall acceptance of POCUS use.

[Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use Glucose Meter].

BACKGROUND: A point-of-care glucose testing (POCT) is an essential component of care in patients with hyperglycemia and hypoglycemia in inpatient and outpatient settings. In Russian medical facilities (MFs), conventional glucose meters designed for self-monitoring by patients with diabetes are commonly used for POCT. These home-use meters have two serious disadvantages: the first is large measurement bias and the second - they can't be integrated into laboratory information systems, so measurement data have to be recorded into patient charts manually. Both factors may lead to medical errors. It is reasonable to use in the MFs specialized POCT glucose meters, as they are superior to conventional ones in accuracy and may be easily connected to laboratory information systems. With this in mind, physicians at the Russian Children's Clinical Hospital decided to substitute conventional meters with the Accu-Chek Inform II POCT meter, however, after preliminary performance assessment of the model. AIM: To test the Accu-Chek Inform II performance characteristics: accuracy, linearity, repeatability, and mean absolute relative difference (MARD). MATERIALS AND METHODS: Performance of the Accu-Chek Inform II was tested by comparing the results of parallel CGL measurements with the meter and reference laboratory analyzer in capillary blood samples. Overall, 99 parallel CGL measurements were made in 45 samples. Accuracy was evaluated according to the ISO 15197-2013 and POCT12-A3 criteria. RESULTS: The Accu-Chek Inform II meter met the requirements of ISO 15197-2013 and POCT12-A3 and demonstrated high linearity (correlation coefficient, r=1,0), good repeatability (mean coefficient of variation, CV=1,38%) and acceptable MARD (4,9%). CONCLUSION: The Accu-Chek Inform II POCT glucose meter may be efficiently and safely used in inpatient and outpatient MFs and particularly in pediatric clinics.

Analytical performance and user-friendliness of four commercially available point-of-care devices for C-reactive protein.

INTRODUCTION: Proper implementation of Point-of-Care testing (POCT) for C-reactive protein (CRP) in primary care can decrease the inappropriate use of antibiotics, thereby tackling the problem of growing antimicrobial resistance. OBJECTIVE: The analytical performance and user-friendliness of four POCT-CRP assays were evaluated: QuikRead go easy, LumiraDx, cobas b 101 and Afinion 2. MATERIALS AND METHODS: Imprecision was evaluated using plasma pools in addition to manufacturer-specific control material. Trueness was assessed by verification of traceability to ERM-DA474/IFCC in parallel to method comparison towards the central laboratory CRP method (cobas c 503) using i) retrospectively selected plasma samples (n = 100) and ii) prospectively collected capillary whole blood samples (n = 50). User-friendliness was examined using a questionnaire. RESULTS: Between-day imprecision on plasma pools varied from 4.5 % (LumiraDx) to 11.5 % (QuikRead). Traceability verification revealed no significant difference between cobas c 503 CRP results and the ERM-DA474/IFCC certified value. cobas b 101 and Afinion achieved the best agreement with the central laboratory method. LumiraDx and QuikRead revealed a negative mean difference, with LumiraDx violating the criterion of > 95 % of POCT-CRP-results within ± 20 % of the comparison method. Regarding user-friendliness, Afinion obtained the highest Likert-scores. CONCLUSION: The analytical performance and user-friendliness of POCT-CRP devices varies among manufacturers, emphasizing the need for quality assurance supervised by a central laboratory.

Point-of-Care HbA1c in Clinical Practice: Caveats and Considerations for Optimal Use.

Hemoglobin A1c (A1C) is widely used for the diagnosis and management of diabetes. Accurate measurement of A1C is necessary for optimal clinical value. Assay standardization has markedly improved the accuracy and consistency of A1C testing. Devices to measure A1C at point of care (POC) are commercially available, allowing rapid results when the patient is seen. In this review, we describe how standardization of A1C testing was achieved, leading to high-quality results in clinical laboratories. We address the use of POC A1C testing in clinical situations and summarize the advantages and disadvantages of POC A1C testing. We emphasize the importance of considering the limitations of these devices and following correct testing procedures to ensure that accurate A1C results are obtained for optimal care of patients.

Performance evaluation and characterization of pre-analytical effects by sample types and storage conditions on tumor marker measurement by the point-of-care test platform IchromaTM II.

Tumor markers should be measured regularly and accurately to prevent, diagnose, and monitor cancers efficiently. We aimed to characterize the pre-analytical factors effecting on the analytical performance of point-of-care test (POCT) platform IchromaTM II (Boditech Med Inc., Gangwon-do, Korea) for alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and prostate specific antigen (PSA) and evaluate their consequences in clinical practice. Based on comprehensive evaluation for the analytical performance of IchromaTM II including precision, linearity, and method comparison performed according to CLSI guidelines, pre-analytical factors of sample types and conditions were extensively analyzed. A total of five sample types [serum, plasma (PL) and whole blood (WB) from EDTA tube, PL and WB from sodium heparin tube] from 40 patients were used for comparing among specimen types. Additionally, stability was assessed up to 21 h at room temperature, refrigerated for 8 days, and frozen for 16 weeks by using 4 levels of pooled patient samples which were measured in triplicate. Precision, linearity and correlation with central laboratory analyzers observed in all three tumor markers were within acceptable criteria. However, variable degrees of percent deviations were observed according to sample type and storage conditions. Only EDTA PL samples presented clinically acceptable percentage biases for all three tumor markers when stored at room temperature or refrigerated condition. Positive bias of CEA and PSA in storage duration until 16 weeks were observed when stored in frozen condition. While IchromaTM II showed an adequate analytical performance as a POCT platform with simple operating procedures for the measurement of tumor markers, clinical laboratories should be aware of stability issues when different types of blood specimens are practically utilized.

Implementing point-of-care hemoglobin A1C testing in an obstetrics outpatient clinic.

BACKGROUND: A1C ≥6.0% is associated with increased risk of adverse outcomes in pregnant diabetic patients. A1C testing is recommended by the American Diabetes Association as a secondary measure of glycemic control in pregnant patients. OBJECTIVE: To determine the utility of A1C point-of-care testing (POCT) during pregnancy to facilitate rapid counseling and diabetes care, particularly in relatively low-income transient patient populations. METHODS: We performed a single-center, retrospective analysis of patients presenting to an outpatient obstetrics office with routine, in-laboratory A1C testing, before and after the implementation of POCT for A1C (n = 70 and n = 75, respectively). Demographics, results, physician referral to a nutritionist, counseling, and outcomes were retrieved from patient electronic medical records. RESULTS: In total, 9% and 23% of the in-laboratory and POCT groups, respectively, were referred for nutrition services (P = .02). Of these, 22% of the in-laboratory group and 42% of the POCT group received immediate counseling (P < .01). An inverse correlation was observed between A1C level at study entry and gestational weeks at delivery, with a Pearson r value of -0.39 (-0.58 to -0.16) for the in-laboratory group and -0.38 (-0.57 to -0.14) for the POCT group. No statistically significant difference in pregnancy outcomes was observed. CONCLUSION: Implementation of A1C POCT was associated with immediate counseling and management of the health of pregnant patients, but was not associated with improved outcomes, in a low-resource patient population.

CoaguChek and Coag-Sense PT2 Meter Point of Care INR Device Validation.

OBJECTIVE: To standardize international normalized ratio (INR) measurements and improve data integrity by enabling electronic result transmission for warfarin monitoring, two point-of-care (POC) devices were evaluated against an internal plasma INR reference method. METHODS: A multicenter study was pursued (January 24, 2022, through October 19, 2022) to compare concordance of two commercially available POC devices, Coag-Sense PT2 Meter (Coag-Sense) and CoaguChek XS Pro and Plus devices (CoaguChek), against an internal plasma INR method among patients treated with warfarin. Bias and linear regression analysis were assessed for these devices including dosing decision accuracy compared with plasma INR reference. RESULTS: Two hundred ninety-nine patients treated with warfarin across three Mayo Clinic sites agreed to participate. Atrial fibrillation (n=191, 63.9%), venous thromboembolism (n=65; 21.7%), and heart valve prosthesis (n=46; 15.4%) were common anticoagulant indications with a 2.5 INR target for 280 (93.6%) of patients. For the CoaguChek devices, 243 (81.3%) of values fell within 0.2 INR units with plasma INR referent and 285 (95.3%) within 0.4 units (R2=0.93). For the Coag-Sense device, 102 (34.1%) of values fell within 0.2 INR units and 180 (60.2%) within 0.4 INR units of plasma INR values, (R2=0.83; P<.0001). Using the plasma INR as the gold standard, appropriate dosing recommendations would have occurred for 292 (97.7%) of the CoaguChek and 244 (81.6%) of the Coag-Sense results. CONCLUSION: Compared with a plasma referent, INR values obtained from the CoaguChek devices exhibited less systematic bias compared with Coag-Sense measures. This translates to a greater percentage of concordant management decisions between POC and laboratory INR methods.

Estudio comparativo de equipos INR capilar "point of care" versus INR venoso, en pacientes en tratamiento con antagonistas de vitamina K / Comparison of point of care capillary international normalized ratio (INR) with INR measured in venous samples

Background: INR is used to monitor the treatment with vitamin K antagonists. A strategy to reduce waiting times for sampling is to measure INR in a capillary sample using a portable point of care (POC) type coagulometer. Aim: To evaluate the correlation of CoaguChek Pro II™, Xprecia™ and microINR™ with venous INR measured at the clinical laboratory and their ease of use. Materials and Methods: Patients provided capillary and venous blood samples for parallel tests comparing Xprecia™ Stride with CoaguChek Pro II™ and with venous INR, microINR™ with CoaguChek Pro IITM and with venous INR. The devices' ease of use was assessed surveying the sampling staff. Results: The three tested devices had good correlation coefficients with venous INR: CoaguChek Pro IITM 0.953 and 0.962; Xprecia™ of 0.912 and microINR™ of 0.932. The correlation coefficient of Xprecia™ with CoaguChek Pro IITM was 0.937 and microINR™ with CoaguChek Pro IITM was 0.976. Conclusions: CoaguChek Pro IITM, Xprecia™ and microINR™ results had a good correlation coefficient with INR measured at the laboratory. Our results indicate that, in the hands of trained users, POC-type coagulometers are reliable and acceptable for routine use in anticoagulant treatment control.

Is point-of-care accurate for indicating thrombolysis in anticoagulated patients on oral anticoagulation treatments? / Teste rápido de RNI tem acurácia para indicar trombólise em pacientes em uso de anticoagulante oral?

The use of oral anticoagulation treatment (OAT) in patients with an international normalized ratio (INR) higher than 1.7 is a contraindication to thrombolysis in acute ischemic stroke. The aim of the present study is to compare the use of point-of-care (POC) coagulometers to the standard coagulation analysis (SCA) procedure of the INR as a decision-making test for use with patients taking OAT. Method: Eighty patients on chronic OAT underwent a POC and an SCA during a regular outpatient evaluation. Results: When comparing the abilities of the POC test and the SCA test to identify adequate levels for thrombolysis (≤1.7), the POC had a sensitivity of 96.6% (95%CI 88.4-99.1) and a specificity of 60.0% (95%CI 38.6-78). POC overestimated INR levels by 0.51 points compared to the SCA test. Conclusion: POC has a high sensitivity compared to the SCA test for the identification of patients within the cut-off point for thrombolysis. .

Valores acima de 1.7 no RNI de pacientes em uso de terapia anticoagulante (ACO) é uma contraindicação para a trombólise no AVC isquêmico. O Objetivo do presente estudo é comparar o teste capilar rápido (TCR) com o exame tradicional de RNI como método de decisão para indicação de terapia trombolítica em pacientes em uso de ACO. Método: Oitenta pacientes em uso crônico de ACO foram submetidos ao TCR e ao exame tradicional durante consulta ambulatorial. Resultados: Ao serem comparados os resultados do TCR com o exame tradicional com o ponto de corte de 1,7 de RNI, o teste rápido teve sensibilidade de 96,6% (IC95% 88,4-99,1) e especificidade de 60,0% (IC95% 38,6-78). O TCR superestimou os níveis de RNI em 0,51 pontos comparado ao exame tradicional. Conclusão: O TCR apresentou elevada sensibilidade, comparado ao exame tradicional para a identificação de pacientes em uso de ACO com indicação de trombólise. .

RNI Point-of-care test (POCT): esperança ou ilusão? / Point-of-care test (POCT) INR: hope or illusion?

Na última década, foram desenvolvidos os testes point-of-care visando à geração rápida de resultados de exames. Na área da hemostasia, a razão normatizada internacional, o RNI point-of-care test (RNI-POCT), constitui o principal exame dessa nova proposta. Esse teste tem grande potencial de benefício em situações em que o resultado rápido da RNI influencia a tomada de decisão clínica, como no acidente vascular cerebral isquêmico agudo, antes de procedimentos cirúrgicos e durante cirurgias cardíacas, além de permitir que o próprio paciente faça a monitoração da anticoagulação oral. Entretanto, a precisão e a acurácia da RNI-POCT ainda precisam ser aprimoradas para aumentar a eficácia e a eficiência do teste. A RDC/ANVISA Nº 302 deixa claro que os testes POCT devem ser supervisionados pelo responsável técnico do Laboratório Clínico nas fases pré-analítica, analítica e pós-analítica. Na prática, o laboratório não participa da execução desses testes e liberação dos resultados, não sendo, portanto, o mais indicado para garantir a qualidade dos mesmos. Os clínicos, especialmente aqueles envolvidos com a anticoagulação oral de pacientes, têm grande expectativa na incorporação da RNI-POCT na prática diária, apesar das limitações desse método. Esses profissionais mostram-se dispostos a treinar o paciente para realizar o teste, mas legalmente não são os responsáveis pela qualidade do mesmo e não estão preparados para a manutenção dos equipamentos. A definição do responsável pelo RNI-POCT precisa ser reavaliada pelos órgãos competentes, de forma a garantir que seja cumprida, e constitui etapa essencial para assegurar a qualidade do teste e, consequentemente, sua maior utilização.

In the last decade, point-of-care tests were developed to provide rapid generation of test results. These tests have increasingly broad applications. In the area of hemostasis, the international normalized ratio, INR point-of-care test (POCT INR), is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control.

¿Podemos confiar en una glicemia realizada en un glucómetro al lado de la cama del enfermo? / Are blood glucose measurements made with portable glucometers reliable?

Examinations performed beside the bed of patients ("Point-ofcare testing, POCT") provide immediate results and are simple to perform. The most common of these tests is the self control of blood glucose levels in diabetic patients. The use of these devices at the hospital level, introduces a new set of requirements to health institutions, which should monitor all aspects of the process, including training of final users, proper quality control, development of written procedures for use and even participation in surveys of external quality control, avoiding the generation of errors and guaranting patient safety (Rev Méd Chile 2009; 137:1261-4).

Los exámenes realizados al lado de la cama del enfermo ("Point of care testing, POCT") tienen como mayor ventaja la rapidez en la entrega de resultados y la simplicidad de uso, siendo su principal aplicación el autocontrol de la glicemia en pacientes diabéticos. El uso de estos equipos a nivel hospitalario introduce exigencias a las instituciones de salud, las cuales deben monitorizar todos ¡os aspectos del proceso, incluyendo la capacitación de los usuarios, el adecuado control de calidad, el desarrollo de procedimientos escritos para su uso e inclusive la participación en encuestas de control de calidad externo, evitando la generación de errores y colaborando así con la seguridad del paciente.

Comparison between cardiac output values measured by thermodilution and partial carbon dioxide rebreathing in patients with acute lung injury

CONTEXTO: A termodiluição, considerada técnica padrão para medida do débito cardíaco em pacientes graves, não é isenta de riscos relevantes. Faz-se necessário encontrar métodos alternativos não invasivos, automáticos, simples e acurados para monitorar o débito cardíaco à beira do leito. OBJETIVO: Comparar as medidas do débito cardíaco obtido com os métodos termodiluição e reinalação parcial de gás carbônico em pacientes com lesão pulmonar aguda em dois níveis de gravidade (índice de lesão pulmonar - LIS abaixo de 2,5 grupo A; e acima de 2,5, grupo B). TIPO DO ESTUDO: Comparativo, prospectivo, controlado. LOCAL: Unidades de Terapia Intensiva de dois hospitais-escola. MÉTODOS: Vinte pacientes acometidos de insuficiência respiratória aguda (PaO2/FiO2 < 300), sob ventilação pulmonar artificial, nos quais foram realizadas 294 medidas, 164 medidas no grupo A (n = 11) e 130 no grupo B (n = 9),variando de 14 a 15 medidas por paciente, foram estudados. Débito cardíaco foi medido com termodiluição e reinalação parcial de gás carbônico. RESULTADOS: A correlação entre os métodos estudados foi fraca no grupos A (r = 0,52, p < 0,001*) e no B: r = 0,47, p < 0,001*). A aplicação do teste de Bland-Altman permitiu evidenciar a discordância entre os métodos (grupo A: -0,9 ± 2,71 l/min; IC 95% = - 1,14 a -0,48; e grupo B: -1,75 ± 2,05 l/min (IC 95% = -2,11 a -1,4). A comparação dos resultados (testes t para grupos emparelhados e Mann-Whitney) obtidos nos grupos e entre os grupos de estudo revelou diferenças ( p = 0,00*, p < 0,05). DISCUSSAO: Erros em estimar o CaCO2 (conteúdo arterial de CO2) através da ETCO2 (CO2 de final de corrente) e situações de circulação hiperdinâmica associados a espaço morto e/ou shunt possivelmente expliquem nossos resultados. CONCLUSAO: Em pacientes com lesão pulmonar aguda, o débito cardíaco determinado pela reinalação parcial de gás carbônico difere dos valores medidos com termodiluição. Esta diferença se acentua com a maior gravidade da lesão pulmonar.

Comparison of outpatient point of care glucose testing vs venous glucose in the clinical laboratory

The purpose of this study was to evaluate the accuracy of glucometers in assessing glucose levels in outpatients. The investigation consisted in the analysis of retrospective validation data (obtained at the Clinical Laboratory of the Puerto Rico Medical Services Administration) and the analysis of data obtained from forty outpatients. Glucose concentration was obtained from these outpatient samples using the patients' glucometers and a clinical laboratory analyzer (hexokinase method). Statistical analysis included descriptive and correlation measures and t-test. Results revealed that accurate glucose values were obtained by the glucometers utilized in both the validation process and the outpatients (POCT) procedure. The investigation also demonstrated the need by outpatients to receive proper training in handling their glucometers.